Clever Culture Systems submits FDA 510(k) for the APAS Independence

21 December 2018

Press Release

Clever Culture Systems AG (CCS) is pleased to announce that it has filed a 510(k) application with the United States Food and Drug Administration (FDA) for its APAS® Independence instrument with associated Urine Analysis Module.

This important milestone for the Company supports the expected commercial launch of the APAS® Independence instrument in the United States in 2019.  Obtaining FDA clearance for the APAS® Independence instrument facilitates commercial market access and the ability for sales to commence in the single largest pathology market globally.  This submission follows the recent placement of the first APAS® Independence instrument in the United States (for investigational use) into Hennepin Healthcare System, a laboratory in Minneapolis.  It is expected that a number of initiatives targeting early market awareness will occur during 2019 calendar year to build up the early sales pipeline in the US.

FDA de novo achievement for APAS®

A de novo application is required when there is no existing predicate device cleared by the FDA.  In October 2016, Clever Culture Systems received a clearance for its 510(k) de novo submission, which the FDA cleared for APAS® as a Class II medical device.  The de novo submission used a manual version of APAS® to test 10,000 patients in a series of clinical trials conducted in the US and Australia over a 12-month period.  This achievement demonstrated the core artificial intelligence and imaging capability of APAS®, de-risked the regulatory path to market and was a global first.

FDA 510(k) for APAS® Independence

A 510(k) submission requires new devices to be comparable or substantially equivalent to existing predicate device(s) already previously cleared by the FDA.  CCS is the originator for the predicate device of APAS® and has access to the complete data on both the APAS® manual loading instrument and the fully automated APAS® Independence instrument, representing an expected straight forward path for 510(k) review.  The Company is not aware of any competing 510(k) submissions against its predicate, once again making this a global first.

Timing

The FDA has a very clear and transparent 510(k) submission process.  Once the 510(k) is submitted, there is a 90-calendar day review process.  There are a number of opportunities for the Company and the FDA to communicate as part of the detailed review process, and during this time the 90-calendar day process may or may not stop depending on the nature of the review questions.  The Company expects to have a collaborative dialogue and set of questions and answers with the FDA as it did during the de novo application.

Clever Culture Systems General Manager, Peter Bradley, said:

“It is said that it takes a village to raise a child. In this case that child has been the APAS® Independence and it has taken the hard work of both joint venture partners and several other collaborators to get us to this key milestone. We are excited at the possibility of releasing the first FDA cleared Class II commercial product of its kind available for sale in the US during 2019.  This milestone is underpinned by our established centre of excellence reference site and will be supported by activity in early 2019 to build awareness leading up to the FDA decision.”